Ad Hoc Disease Transmission Advisory Committee: A Report to the OPTN/UNOS Board

1. Ad Hoc Disease Transmission Advisory Committee:A Report to the OPTN/UNOS Board Emily A. Blumberg, MD, Chair Michael D. Green, MD, MPH, Vice Chair Shandie Covington, Staff Liaison June 25-26, 2012 Richmond, Virginia

2. BOD Approved Committee Projects • DTAC News e-newsletter • Ongoing as needed to share information • Guidance for considering donor with meningoencephalitis of unknown etiology • Reviewed at this meeting • Proposed Minimum Screening Requirements for Living Donors • Feedback to Living Donor Committee on this proposal during development

3. Ongoing BOD Approved Committee Projects • Improvements to disease reporting page on Improving Patient Safety portal • Business Requirements being finalized, then to Exec Committee for placement into programming queue • Follow-up survey of all OPOs regarding donor screening practices • Remains on hold pending release of finalized US PHS Guidelines, as this is expected to change OPO screening practices to some degree

4. US PHS Guidelines Update • CDC reviewed all responses received from Fall 2011 public comment period. • Overview of modifications to the Guidelines shared publically at the American Transplant Congress talk on June 5 • Call with the Expert Review Panel held on June 11 to review revised recommendations. • Feedback from call submitted no later than June 15.

5. Universal Donor Health Questionnaire • Multi-organizational stakeholder group worked on this effort. • DTAC provided feedback early on and had an unofficial representative on working group • 2 forms planned- adult and <12 y/o. • Peds (<12 y/o) form still being finalized • Final adult document out and in beta testing phase now. • far more generally worded than AOPO format of medical-social history

6. Potential Donor Derived Transmission Events 7

7. Potential Donor Derived Transmission Events 2011 *all unlikely or excluded

8. Infections * Scopulariopsis, LCMV, WNV, HHV8, CMV, Toxoplasmosis; ** Scopulariopsis,WNV, LCMV

9. Malignancies * Includes paraganglioma, choriocarcinoma, and urothelial cell carcinoma

10. What Has DTAC Learned? * Subject to change after extended follow-up **Cases reported include some donors recovered in previous years.

11. DTAC 2011-2012 Dr. Emily Blumberg (Chair, TID) Dr. Mike Green (Vice Chair, Peds TID) Ms. Carrie Comellas (TX Coord) Dr. Ed Dominguez (TID) Dr. Afshin Ehsan (Thoracic Surgeon)Barry Friedman (TX Admin) Dr. Tom Gross (Peds Hem/Onc) Dr. Dan Kaul (TID) Dr. Shimon Kusne (TID) Dr. Marshall Lyon (TID) Dr. Rachel Miller (TID) Ms. Samantha Mitchell (OPO) Dr. Michael Nalesnik (Pathology)Dr. Volker Nickeleit (Pathology) Dr. Martha Pavlakis (Nephrology) Dr. Tim Pruett (Abd TX Surgeon) Dr. Phillip Ruiz (Pathology) Dr. Michael Souter(OPO Med Dir) Dr. Betsy Tuttle-Newhall (Abd Surgeon) Ms. Linda Weiss (OPO Lab Dir) Dr. Russ Wiesner (Hepatologist) Dr. Susan Hocevar (CDC) Dr. Jim Bowman (HRSA) Dr. Bernie Kozlovsky (HRSA) Ms. Raelene Skerda (HRSA) Dr. Karen Near (HRSA)

12. Questions? Thank you! Dr. Michael Green Shandie Covington Children’s Hospital of UNOS Pittsburgh of UPMC Sr. Patient Safety Specialist Incoming Chair Liaison Michael.Green@chp.edushandie.covington@unos.org (412) 692-6111 (804) 782-4929 Special thanks to Sarah Taranto, Kimberly Taylor, Kimberly Parker, Cassandra Meekins as well as the entire Committee!

14. ***RESOLVED, that the OPTN request a meeting with the HHS to discuss the proposed U.S. Public Health Service Guidelines for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) through Solid Organ Transplantation before such guidance is approved, in order to discuss the potential impact on OPTN policies, in accordance with the Final Rule § 121.4 (2), which requires that OPTN policies be consistent with recommendations of the CDC, for the testing of organ donors and follow-up of transplant recipients to prevent the spread of infectious diseases.